ReviewClinical pharmacology and therapeutics2022
The Structured Process to Identify Fit-For-Purpose Data: A Data Feasibility Assessment Framework.
Review in Clinical pharmacology and therapeutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
41 citing papers in PubMed.
- Choosing real-world data for clinical and epidemiological research: methodological lessons from NHIRD and TriNetX-A narrative review.Annals of medicine · 2026Review
- PCORsearch: A scalable, user-centric platform for self-service cohort discovery and feasibility analysis of PCORnet data.Computational biology and chemistry · 2026Article
- Integrated Evidence Generation Planning: Why Medical Affairs is a Critical Partner.Pharmaceutical medicine · 2026Article
- Systematic Evaluation of Data and Trial Fitness for Oncology Trial Emulation: Empirical Findings from the CARE Initiative.Clinical pharmacology and therapeutics · 2026Article
- Application of the Target Trial Emulation Framework to Studies in the Pediatric Population.The Journal of pediatrics · 2026Article
- Evaluating Data Quality by Proxy: Can We Evaluate All Dimensions of the European Medicines Agency Data Quality Framework for Registry-Based Post-Authorization Safety Studies?Pharmacoepidemiology and drug safety · 2026Article
- Real-world data landscape for glaucoma in Europe: a questionnaire-based analysis of resources among European Glaucoma Society members.BMJ open ophthalmology · 2025Article
- Finding the right tool for the specific task: navigating RWE tools and checklists.Future oncology (London, England) · 2025Review
- Navigating the Real World: A Scoping Review of Structured Frameworks to Effectively Identify, Evaluate, and Select Real-World Data Sources for Fit-for-Purpose Studies.Clinical pharmacology and therapeutics · 2025Article
- Data science for pediatric infectious disease: utilizing COVID-19 as a model.Current opinion in infectious diseases · 2025Review
- Combining Real-World and Clinical Trial Data Through Privacy-Preserving Record Linkage: Opportunities and Challenges-A Narrative Review.Health science reports · 2025Article
- Optimizing Patient Registries for Regulatory Decision Making - Key Learnings From an HMA/EMA Multistakeholder Workshop.Clinical pharmacology and therapeutics · 2025Review
- Real-World Evidence Acceptability and Use in Breast Cancer Treatment Decision-Making in the United States: Call-to-Action from a Multidisciplinary Think Tank.Advances in therapy · 2025Article
- Stakeholders' Perspectives Toward the Use of Patient Registry Data for Decision-Making on Medicines: A Cross-Sectional Survey.Drug safety · 2025Article
- Development of a Physiologically Based Biopharmaceutics Model Report Template: Considerations for Improved Quality in View of Regulatory Submissions.Molecular pharmaceutics · 2025Review
- Increasing the Utility of Real-World Data to Inform Public Health Decision Making Through a US-based Private-Public Partnership: 10 Lessons Learned from a Principled Approach to Rapid Pandemic RWE Generation.Therapeutic innovation & regulatory science · 2025Article
- Clinical Profile and Treatment Patterns in Individuals with Type 2 Diabetes and Chronic Kidney Disease Who Initiate a GLP-1 Receptor Agonist: A Multinational Cohort Study.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2025Article
- Advancing Principled Pharmacoepidemiologic Research to Support Regulatory and Healthcare Decision Making: The Era of Real-World Evidence.Clinical pharmacology and therapeutics · 2025Review
- Article
- Real-World Data and Real-World Evidence in Regulatory Decision Making: Report Summary From the Council for International Organizations of Medical Sciences (CIOMS) Working Group XIII.Pharmacoepidemiology and drug safety · 2025Review
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
To complement real-world evidence (RWE) guidelines, the 2019 Structured Preapproval and Postapproval Comparative study design framework to generate valid and transparent real-world Evidence (SPACE) framework elucidated a process for designing valid and transparent real-world studies. As an extension to SPACE, here, we provide a structured framework for conducting feasibility assessments-a step-by-step guide to identify decision grade, fit-for-purpose data, which complements the United States Food and Drug Administration (FDA)'s framework for a RWE program. The process was informed by our collective experience conducting systematic feasibility assessments of existing data sources for pharmacoepidemiology studies to support regulatory decisions. Used with the SPACE framework, the Structured Process to Identify Fit-For-Purpose Data (SPIFD) provides a systematic process for conducting feasibility assessments to determine if a data source is fit for decision making, helping ensure justification and transparency throughout study development, from articulation of a specific and meaningful research question to identification of fit-for-purpose data and study design.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.